TN governor signs bill easing compounding pharmacy rule

Apr. 30, 2013

Gov. Bill Haslam / AP / File

Written by

Walter F. Roche Jr.

The Tennessean

Gov. Bill Haslam has quietly signed into law a bill that eliminates a Tennessee requirement that pharmacists have a patient-specific prescription before dispensing a specially compounded drug.

The measure, which was backed by the Tennessee Pharmacists Association and sponsored by two legislators who are licensed pharmacists, comes in the wake of a nationwide fungal meningitis outbreak blamed on a Massachusetts drug compounding firm.

Alexia Poe, spokeswoman for the governor, said state Health Department officials worked with legislators to put in safeguards to ensure patient safety.

Those provisions include a requirement that pharmacists doing compounding file quarterly reports with the state on the volume of compounded drugs they are producing. That reporting requirement, however, does not apply to hospital pharmacies.

But the governor’s approval drew strong criticism from Dr. Michael Carome of Public Citizen, a nonprofit advocacy group.

“The governor’s decision to sign this bill undermines patient safety in Tennessee and represents a substantial step in the wrong direction,” Carome said.

He said the bill opens the door to “the large-scale production of drugs that have not been approved by the FDA nor manufactured according to high safety and quality standards that patients in this country expect.”

He said the “minimal safeguards added to the bill are not sufficient to address the bill’s serious shortcomings.”

Poe noted that the bill requires pharmacists to report to the state board if they have been subject to disciplinary action in some other jurisdiction.

New England Compounding, the company blamed for the meningitis outbreak, failed to inform Tennessee officials that it had been subject to a cease-and-desist order from the Colorado pharmacy board.

Sponsors of the bill contend that the measure will allow Tennessee pharmacists to produce batches of compounded drugs to address drug shortages and reduce reliance on companies like New England Compounding.

“The intent of the bill was to address medication shortages, which the Department of Health saw as a valid concern. Simply put, the department believes patients deserve both safe and available medications,” Poe said.